Federal health experts warn that the same dangerous conditions that led to a nationwide fungal meningitis outbreak were present at a second compounding pharmacy, which is now recalling all of its injection drugs.
An Ameridose drug recall was announced by the FDA on October 31, indicating that preliminary findings of an inspection have raised concerns about a lack of sterility assurance for products produced and distributed by the facility. As a result all unexpired Ameridose drugs have been recalled.
Ameridose is a Massachusetts compounding pharmacy that is owned by the same principals that own the New England Compounding Center (NECC), whose recalled epidural steroid injections have been linked to a fungal meningitis outbreak that has killed 28 people and sickened nearly 400.
FDA investigators are in the process of inspecting Ameridose’s facilities, but warn that sterility problems at the facility could represent a serious health risk for consumers.
Investigators believe that sterility problems led to NECC distributing more than 17,000 vials of tainted steroid injections, and the U.S. Centers for Disease Control and Prevention (CDC) warns that an estimated 14,000 people who received those injections may be at risk for fungal meningitis or other infections.
FDA officials said that while Ameridose is recalling all of its products that have not expired and doctors should not use any they have in stock, at this stage there is no sign that the drugs are contaminated. Therefore, doctors are not being advised to follow up with patients who received Ameridose drugs.
There are some concerns, however, that the shut downs may lead to a drug shortage. The FDA warns that some of the drugs linked to the Ameridose recall were on the critical drug shortage list already.
“The FDA’s top priority is to ensure that drugs are safe for the American public,” said FDA Commissioner Margaret A. Hamburg, M.D. “The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies.”
Doctors and patients with questions can contact the FDA’s Drug Information Line at (855) 543-DRUG (3784) and can press * to get information on the Ameridose recall.
Ameridose drugs can be identified by the company logo or its name. A complete list of Ameridose products affected by the recall are on the company’s website at www.Ameridose.com. Customers with questions can contact Ameridose by calling (888) 820-0622 or by emailing the company at email@example.com.